Section 493.1100 - Condition: Facility administrationEach laboratory that performs nonwaived testing must meet the applicable requirements under §§ 493.1101 through 493.1105 , unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7 ).
(a)Reporting of SARS-CoV-2 test results. During the Public Health Emergency, as defined in § 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe.68 FR 3703, Jan. 24, 2003, as amended at 85 FR 54873, Sept. 2, 2020